medical technology

1. ROAD TO MEDICAL INNOVATION & ACCESS:
FROM A REAR-VIEW MIRROR
Global Health Histories Seminar Series
11 July 2012
Geneva, WHO Headquarters
Zafar Mirza
Department of Public Health, Innovation and Intellectual Property

2. THE PRESENTATION
1. Unpacking the concepts
2. Evolution of medical innovation
3. Evolving business model
4. Conclusions

3. MEDICAL INNOVATION AND ACCESS
unpacking the concepts
1. Medical Technologies?
2. Medical Innovation?
3. Access?

4. Purpose / Application
• Prevention : Vaccines;
Iodized Salt
• Screening : pap smear;
mammography
• Diagnosis : ECG; Blood
Tests
• Treatment : ARVs,
Appendectomy
• Rehabilitation:Hearing Aid;
Physiotherapy
MEDICAL TECHNOLOGIES
Material Nature
• Pharmaceuticals
• Biologics
• Medical devices
• Miscellaneous
• Medical & surgical procedures
• Support systems
• Managerial systems

5. MEDICAL INNOVATION
• Health innovation & medical innovation
• Innovation & R&D
• Innovation in medical technologies
• Is it just R&D in medical technologies?
• Specific context of debate on innovation in medical
technologies

6. HOW MEDICAL INNOVATION IS DIFFERENT?
1. Sine qua non of health development
2. Public good dimension
3. Discovery is supported by public sector
4. Drug development is long, expensive & risky
5. End products are protected through patents
6. End products are strictly regulated
7. Equitable access to innovations is critical.

8. ACCESS TO MEDICAL TECHNOLOGIES
1. Rational
selection
4. Reliable
health and
supply
systems
2. Affordable
prices
3. Sustainable
financing
ACCESS
MEDICAL
INNOVATION

9. 1. Problems in access to generic medicines
• health system related issues
ACCESS TO MEDICAL TECHNOLOGIES
two main sets of issues
medicines price surveys data: average
availability12 of selected essential medicines
was 51.8 per cent in public sector health
facilities and 68.5 per cent in the private
sector over the period 2007-2011
e.g. in 2000 very few people with
HIV/AIDS in developing countries were
on treatment, in 2011 6.6 million of them
have access to first line ARVs, yet 8
million still wait for the treatment

10. 2. Problems in access to patent protected
medicines
ACCESS TO MEDICAL TECHNOLOGIES
two main sets of issues
In March 2012, India granted its first compulsory
license, allowing a domestic drug maker to
manufacture generic version of Nexavar, a cancer
drug by Germany's Bayer. That enabled India's Natco
Pharma to sell its generic version of Nexavar at INR
8,800 rupees ($160) per monthly dose, a fraction of
the INR 280,000 ($5090) rupees Bayer's version cost.

11. EVOLUTION OF MEDICAL INNOVATION
• Medicine and medical technology…
• Two approaches…looking from which side
• Three mile-stone medical innovations:
• Vaccine: Small-pox vaccine 1796
• Medical device: Hypodermic syringe 1844
• Pharmaceutical: Arsphenamine: 1910

12. EVOLUTION OF MEDICAL INNOVATION
FROM EDWARD JENNER TO GAVI
• Up to 20% of deaths in Europe were
dues to smallpox in 19th century
• The last case of smallpox occurred in 1977.
• 2.5 million deaths each year are prevented.
• Between 80-90% of infants receive DPT
vaccine
VACCINE-PREVENTABLE
INFECTIOUS AGENTS OR
DISEASES
ANTHRAX
DIPHTHERIA
CHOLERA
H. INFLUENZAE TYPE B (HIB)
HEPATITIS A
HEPATITIS B
HEPATITIS E
INFLUENZA
JAPANESE ENCEPHALITIS
MEASLES
MENINGOCOCCAL DISEASE
MUMPS
PERTUSSIS (WHOOPING COUGH)
PNEUMOCOCCAL DISEASE
POLIO
ROTAVIRUS (SEVERE DIARRHEA)
RUBELLA (GERMAN MEASLES)
TETANUS (LOCKJAW)
TICK BORNE ENCEPHALITIS
TUBERCULOSIS
TYPHOID FEVER
VARICELLA (CHICKENPOX)
YELLOW FEVER

13. EVOLUTION OF MEDICAL INNOVATION
FROM EDWARD JENNER TO GAVI
• Global vaccine market 2009 was
US$24 billion 
• US$ 1.5 billion on vaccine R&D in 2005
• Few manufacturers, expanding in developing
countries, public sector R&D
• HIV, TB, Malaria, DNA vaccines, recombinant
vector vaccines, new delivery methods
• GAVI: committed US$ 7.2 billion by 2011

14. EVOLUTION OF MEDICAL INNOVATION
MEDICAL DEVICES
• Range is broad, from adhesive plaster to MRI
• 1844, Francis Rynd, first recorded
subcutaneous injection.
• 1956, plastic disposable syringe patented
• 1.3 million/year deaths due to unsafe
injections
• Auto-destruct syringes, prefilled syringes

17. EVOLUTION OF MEDICAL INNOVATION
MEDICAL DEVICES
• Global market was USD 210 billion in 2008
• 4/5 sales revenue comes from USA & Europe
• Future trends
• Robotics, genomics and nanotechnology
• Special needs of developing countries
• Regulation of medical devices in weak

18. EVOLUTION OF MEDICAL INNOVATION
PHARMACEUTICALS
• Global market > USD 800 billion
• > USD 80 billion on R&D
• Emerging markets
• Growing mergers
• Generic market
• Rising costs of R&D and declining results

19. # Medicine year Importance
1 Morphine 1827 Commercialized by a pharmacy (Merck), pain
management (Germany)
2 Aspirin 1897 Synthetic salicylic acid was commercialized (Germany)
3. Ether 1842 General anaesthetic, transformed surgery (US)
Arsphenamine 1910 Syphillis Treatment (Hoechst, Germany)
4. Insulin 1922 1st hormone therapy, transformed diabetes management
5. Penicillin 1929 Transformed the treatment of microbial diseases
6 Chlorpromazine
and Haladol
1950
& 1958
Transformed management of psyschosis. (France)
(Belgium)
7 Estrogen+
Progestin
1961 Birth Control Pills, deep social impact (USA)
8 Digoxin 1962 Changed treatment of heart failure and hypertension
(Germany) (France)
9 Furosemide Loop diuretic, effective treatment of hypertension
10 Atorvastatin 1996 Cholesterol lowering medicine (USA)
11 HAART 1996-7 Transforming effect on AIDS patients
L-Dopa (Sweden); Hydrocortisone; Viagra (1996, USA); Ritalin
EVOLUTION OF MEDICAL INNOVATION
DEVELOPMENT OF MOST INFLUENTIAL PHARMACEUTICALS

20. • No patents on penicillin and polio vaccine.
• There is no patent. Could you patent the sun?
Jonas Salk interview 1955
• "Patent medicine" and "patented medicine"
• US Patent Act in 1790, Patent Office in 1802.
• Era of "copying success" and US "Trading with
Enemy Act 1917"
• Compounds, compositions, manufacturing
processes and uses.
HISTORY AND THE EVOLVING BUSINESS MODEL
In 1876 when the German industry was in its infancy and the patent law was yet to be
evolved, Bismarck appointed a committee to study the likely impact of the patent system
on the industry. Committee members also included founders of Siemens and Hoechst.
Their observations made an interesting reading:
Today industry is developing rapidly........monopolization and
abuse of patent rights will inevitably expose large segments of
the industry to serious injury. The government must protect
industry against these dangers...

21. • Patent protection based model has worked
in the USA and Europe but not in
developing countries
• Blockbuster medicines (annual sales > 1$b)
• Patent cliff
• Pharmaceutical Executive salaries
HISTORY AND THE EVOLVING BUSINESS MODEL

22. Annual compensation packages of top 5 CEOs in
pharmaceutical industry
1 J&J William Weldon 2011 US$ 26.7 million
2 Pfizer Ian Read 2011 US$ 25 million
3 Abbott Miles White 2011 US$ 24 million
4 Mylan Robert Coury 2011 US$ 21.3 million
5 Amgen Kevin Sharer 2011 US$ 18.9 million

23. • What TRIPS changed?
• Concerns about innovation for developing
countries
• Market failure of business model for NTDs
• Search for alternatives
• PDPs
• GSPA-PHI
• Consultative Expert Working Group on R&D:
Financing and Coordination
HISTORY AND THE EVOLVING BUSINESS MODEL

24. • Medical innovation cannot be discussed
today without discussion on access.
• Last 200 years of medical innovation have
been more productive than rest of the
recorded human history.
• Today the focus is on enhancing innovation
for developing countries.
• Current business model is showing signs of
exhaustion
• Era of innovation for innovation.
CONCLUSIONS